BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS CORTISOL II

    MDR report key: 23606628 · Received November 20, 2025

    Report

    Report Number
    1823260-2025-04745
    Event Type
    Malfunction
    Date Received
    November 20, 2025
    Date of Event
    October 28, 2025
    Report Date
    December 22, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JFT
    UDI-DI
    04015630939985
    PMA / PMN Number
    K152227
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CALIBRATION AND QC WERE ACCEPTABLE. A GENERAL REAGENT ISSUE WAS EXCLUDED. AN IMAGE FROM THE SAMPLE FOAM DETECTION CAMERA SHOWS A BUBBLE ON THE SAMPLE SURFACE. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE INVESTIGATION DETERMINED THE ISSUE WAS CONSISTENT WITH A SAMPLE QUALITY ISSUE.

    Additional Manufacturer Narrative · 0

    THE ANALYZER'S SERIAL NUMBER IS (B)(6). THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS CORTISOL II RESULTS FOR 1 PATIENT SAMPLE ON A COBAS E 801 ANALYTICAL UNIT. THE INITIAL RESULT WAS 1.5 NMOL/L WITH A DATA FLAG. THE CLINICIAN REQUESTED THAT THE SAMPLE BE REPEATED. THE REPEATED RESULT WAS 368 NMOL/L.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2578490 ELECSYS CORTISOL II FLUOROMETRIC, CORTISOL JFT ROCHE DIAGNOSTICS 88552701 04015630939985

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown